Blood acquisition suspension system

ABSTRACT

A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication No. 60/436,952, filed Dec. 30, 2002 (Attorney Docket No.7404-446), which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] The present invention generally relates to bodily fluid samplingdevices and more specifically, but not exclusively, concerns anintegrated body fluid sampling device that is adapted to temporarilyremove and reapply the test strip to the incision site.

[0003] General Fluid Testing

[0004] The acquisition and testing of bodily fluids is useful for manypurposes, and continues to grow in importance for use in medicaldiagnosis and treatment, and in other diverse applications. In themedical field, it is desirable for lay operators to perform testsroutinely, quickly and reproducibly outside of a laboratory setting,with rapid results and a readout of the resulting test information.Testing can be performed on various bodily fluids, and for certainapplications is particularly related to the testing of blood and/orinterstitial fluid. Such fluids can be tested for a variety ofcharacteristics of the fluid, or analytes contained in the fluid, inorder to identify a medical condition, determine therapeutic responses,assess the progress of treatment, and the like.

[0005] General Test Steps

[0006] The testing of bodily fluids basically involves the steps ofobtaining the fluid sample, transferring the sample to a test device,conducting a test on the fluid sample, and displaying the results. Thesesteps are generally performed by a plurality of separate instruments ordevices.

[0007] Acquiring—Vascular

[0008] One method of acquiring the fluid sample involves inserting ahollow needle or syringe into a vein or artery in order to withdraw ablood sample. However, such direct vascular blood sampling can haveseveral limitations, including pain, infection, and hematoma and otherbleeding complications. In addition, direct vascular blood sampling isnot suitable for repeating on a routine basis, can be extremelydifficult and is not advised for patients to perform on themselves.

[0009] Acquiring—Incising

[0010] The other common technique for collecting a bodily fluid sampleis to form an incision in the skin to bring the fluid to the skinsurface. A lancet, knife or other cutting instrument is used to form theincision in the skin. The resulting blood or interstitial fluid specimenis then collected in a small tube or other container, or is placeddirectly in contact with a test strip. The fingertip is frequently usedas the fluid source because it is highly vascularized and thereforeproduces a good quantity of blood. However, the fingertip also has alarge concentration of nerve endings, and lancing the fingertip cantherefore be painful. Alternate sampling sites, such as the palm of thehand, forearm, earlobe and the like, may be useful for sampling, and areless painful. However, they also produce lesser amounts of blood. Thesealternate sites therefore are generally appropriate for use only fortest systems requiring relatively small amounts of fluid, or if stepsare taken to facilitate the expression of the bodily fluid from theincision site.

[0011] Various methods and systems for incising the skin are known inthe art. Exemplary lancing devices are shown, for example, in U.S. Pat.No. Re 35,803, issued to Lange, et al. on May 19, 1998; U.S. Pat. No.4,924,879, issued to O'Brien on May 15, 1990; U.S. Pat. No. 5,879,311,issued to Duchon et al. on Feb. 16, 1999; U.S. Pat. No. 5,857,983,issued to Douglas on Jan. 12, 1999; U.S. Pat. No. 6,183,489, issued toDouglas et al. on Feb. 6, 2001; U.S. Pat. No. 6,332,871, issued toDouglas et al. on Dec. 25, 2001; and U.S. Pat. No. 5,964,718, issued toDuchon et al. on Oct. 12, 1999. A representative commercial lancingdevice is the Accu-Chek Softclix lancet.

[0012] Expressing

[0013] Patients are frequently advised to urge fluid to the incisionsite, such as by applying pressure to the area surrounding the incisionto milk or pump the fluid from the incision. Mechanical devices are alsoknown to facilitate the expression of bodily fluid from an incision.Such devices are shown, for example, in U.S. Pat. No. 5,879,311, issuedto Duchon et al. on Feb. 16, 1999; U.S. Pat. No. 5,857,983, issued toDouglas on Jan. 12, 1999; U.S. Pat. No. 6,183,489, issued to Douglas etal. on Feb. 6, 2001; U.S. Pat. No. 5,951,492, issued to Douglas et al.on Sep. 14, 1999; U.S. Pat. No. 5,951,493, issued to Douglas et al. onSep. 14, 1999; U.S. Pat. No. 5,964,718, issued to Duchon et al. on Oct.12, 1999; and U.S. Pat. No. 6,086,545, issued to Roe et al. on Jul. 11,2000. A representative commercial product that promotes the expressionof bodily fluid from an incision is the Amira AtLast blood glucosesystem.

[0014] Sampling

[0015] The acquisition of the produced bodily fluid, hereafter referredto as the “sampling” of the fluid, can take various forms. Once thefluid specimen comes to the skin surface at the incision, a samplingdevice is placed into contact with the fluid. Such devices may include,for example, systems in which a tube or test strip is either locatedadjacent the incision site prior to forming the incision, or is moved tothe incision site shortly after the incision has been formed. A samplingtube may acquire the fluid by suction or by capillary action. Suchsampling systems may include, for example, the systems shown in U.S.Pat. No. 6,048,352, issued to Douglas et al. on Apr. 11, 2000; U.S. Pat.No. 6,099,484, issued to Douglas et al. on Aug. 8, 2000; and 6,332,871,issued to Douglas et al. on Dec. 25, 2001. Examples of commercialsampling devices include the Roche Compact, Amira AtLast, GlucometerElite and Therasense FreeStyle test strips.

[0016] Testing General

[0017] The bodily fluid sample may be analyzed for a variety ofproperties or components, as is well known in the art. For example, suchanalysis may be directed to hematocrit, blood glucose, coagulation,lead, iron, etc. Testing systems include such means as optical (e.g.,reflectance, absorption, fluorescence, Raman, etc.), electrochemical,and magnetic means for analyzing the sampled fluid. Examples of suchtest systems include those in U.S. Pat. No. 5,824,491, issued to Priestet al. on Oct. 20, 1998; U.S. Pat. No. 5,962,215, issued to Douglas etal. on Oct. 5, 1999; and U.S. Pat. No. 5,776,719, issued to Douglas etal. on Jul. 7, 1998.

[0018] Typically, a test system takes advantage of a reaction betweenthe bodily fluid to be tested and a reagent present in the test system.For example, an optical test strip will generally rely upon a colorchange, i.e., a change in the wavelength absorbed or reflected by dyeformed by the reagent system used. See, e.g., U.S. Pat. Nos. 3,802,842;4,061,468; and 4,490,465.

[0019] Blood Glucose

[0020] A common medical test is the measurement of blood glucose level.The glucose level can be determined directly by analysis of the blood,or indirectly by analysis of other fluids such as interstitial fluid.Diabetics are generally instructed to measure their blood glucose levelseveral times a day, depending on the nature and severity of theirdiabetes. Based upon the observed pattern in the measured glucoselevels, the patient and physician determine the appropriate level ofinsulin to be administered, also taking into account such issues asdiet, exercise and other factors.

[0021] In testing for the presence of an analyte such as glucose in abodily fluid, test systems are commonly used which take advantage of anoxidation/reduction reaction which occurs using an oxidase/peroxidasedetection chemistry. The test reagent is exposed to a sample of thebodily fluid for a suitable period of time, and there is a color changeif the analyte (glucose) is present. Typically, the intensity of thischange is proportional to the concentration of analyte in the sample.The color of the reagent is then compared to a known standard whichenables one to determine the amount of analyte present in the sample.This determination can be made, for example, by a visual check or by aninstrument, such as a reflectance spectrophotometer at a selectedwavelength, or a blood glucose meter. Electrochemical and other systemsare also well known for testing bodily fluids for properties onconstituents.

[0022] Testing Difficulties

[0023] Performing the above-discussed steps can be difficult forpatients, especially for patients with limited hand dexterity, such asthe elderly. Typical lancing devices require the user to manually cockthe lancet. As should be appreciated, manual cocking of the device maybe difficult for those with hand dexterity problems. In a typicalprocedure, after cocking the firing mechanism, the patient fires thelancet at the skin in order to form an incision in the skin. Once asufficient amount of fluid collects as a droplet from the incision inthe skin, the patient has to position a test strip over the incisionsite such that the test strip contacts and absorbs a sufficient amountof the fluid for testing. Usually, these droplets of fluid are quitesmall, and patients, especially ones with poor hand motor control, mayexperience great difficulty in positioning the test strip so as tocollect an adequate sample from an individual droplet. As should beappreciated, a patient can become quickly frustrated by this procedureand, consequently, they may perform the test less often or may even quittesting altogether. Moreover, the pressure applied against the skin bythe test strip during sampling can cause the incision to close, therebyprematurely cutting off the fluid supply. If the fluid supply from theincision is cut off too soon, an insufficient amount of the fluid may becollected on the test strip for testing.

[0024] Thus, needs remain for further contributions in this area oftechnology.

SUMMARY OF THE INVENTION

[0025] One aspect the present invention concerns a bodily fluid samplingdevice that temporarily removes a fluid collection means from skin so asto promote fluid formation from an incision in the skin.

[0026] Another aspect concerns a method for sampling bodily fluid. Themethod includes forming an incision the skin with an integratedlancet/sampling device. The device is temporarily withdrawn from theskin to promote fluid formation from the incision. The device is thenreapplied proximal to the fluid or in contact with the skin in order tocollect the fluid.

[0027] Still yet another aspect concerns a bodily fluid sampling deviceable to automatically cock a firing mechanism before lancing the skin.

[0028] Further forms, objects, features, aspects, benefits, advantages,and embodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029]FIG. 1 is a perspective view of a bodily fluid sampling deviceaccording to one embodiment of the present invention.

[0030]FIG. 2 is an enlarged, perspective view of the FIG. 1 device.

[0031]FIG. 3 is a cross sectional view of the FIG. 1 device forming anincision into skin.

[0032]FIG. 4 is a cross sectional view of the FIG. 1 device temporarilyretracted from the skin.

[0033]FIG. 5 is a cross sectional view of the FIG. 1 device configuredto collect fluid from the incision.

DESCRIPTION OF THE SELECTED EMBODIMENTS

[0034] For the purposes of promoting an understanding of the principlesof the invention, reference will now be made to the embodimentsillustrated in the drawings and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended, such alterations andfurther modifications in the illustrated device, and such furtherapplications of the principles of the invention as illustrated thereinbeing contemplated as would normally occur to one skilled in the art towhich the invention relates.

[0035] The present invention generally concerns an integrated skinlancing device that reduces the number of steps involved in forming,collecting, and testing a bodily fluid sample from an incision. Morespecifically, the device is operable to automatically cock the lancingmechanism, and the device is further operable to temporarily lift thedevice from contact with the skin and reposition the device over theincision site in order to collect a fluid sample. By temporarily liftingthe device from the skin, no pressure is applied to the skin by thedevice, which could potentially close the incision and limit the fluidsupply for the sample. In one embodiment, the device includes anelectric motor that automatically cocks the lancing mechanism andtemporarily lifts a fluid collection means from the skin. It iscontemplated that, in another embodiment, a purely mechanical system canbe used to temporarily lift the fluid collection means.

[0036] An integrated bodily fluid sampling device 30 according to oneembodiment, among others, of the present invention will now be describedwith reference to FIGS. 1-2. As depicted in FIG. 1, device 30 includes asampling end portion 32 and an actuation end portion 34. The samplingend portion 32 includes an integrated lancet/sampling device 36, aholder 38 for device 36, and a depth control mechanism 40. Device 36 isconfigured to lance an incision into the skin, collect a bodily fluidsample from the incision, and analyze the fluid sample. In device 36, alancet or blade 42 for forming the incision is housed in a casing 44.For illustration purposes, so that the lancet 42 can be seen in FIG. 1,lancet 42 is shown in an extended state. Normally, when the lancet 42 isnot lancing the skin, the lancet 42 is retracted inside the casing 44.During lancing, the casing 44 is pressed against the skin to form areference surface on which the penetration depth of the lancet 42 isbased. As device 36 is further pressed against the skin, the casing 44slides relative to the lancet 42 such that the lancet 42 is exposed,thereby lancing the incision into the skin. Device 36 further includes atest strip or media 46 for analyzing the fluid sample. The test strip 46can analyze fluid through such means as optical (e.g., reflectance,absorption, fluorescence, RAMAN, etc.), electrochemical, and/or magneticanalysis, to name a few. In one embodiment, the test strip analyzesfluid optically through a chemical reagent. A capillary channel isformed between the casing 44 and the lancet 42, which draws fluid ontothe test strip 46 via capillary action. As previously mentioned theholder 32 holds device 36 during lancing. The depth control mechanism 40is used to control and change the penetration depth of the lancet 42into the skin. For a further discussion of these components in thesampling end portion 32 as well as their function, please refer commonlyowned U.S. patent application Ser. No. 10/330,724 entitled “PRECISIONDEPTH CONTROL LANCING TIP”, filed on Dec. 27, 2002 (attorney referencenumber: 7404-413), which is hereby incorporated by reference in itsentirety. As will be appreciated from the discussion below, the bodilyfluid sampling device 30 according to the present invention can bemodified to be used in conjunction with other types of lancing and/orsampling devices.

[0037]FIG. 2 illustrates an enlarged view of the actuation portion 34 ofthe sampling device 30. So that the actuation portion 34 can be easilyviewed, FIGS. 1 and 2 show the device 30 without a housing. However, itshould be appreciated that device 30 can include a housing in order toprotect the components of device 30 from the outside environment. Asshown, the actuation portion 34 includes a support structure 48 thatsupports a motor 50 as well as a firing mechanism 52. The firingmechanism 52 is used to fire the integrated lancet/sampling device 36 inorder to lance the skin, and the motor 56 is used to cock the firingmechanism 52 as well as to temporarily retract device 36 after lancing.The support structure 48 in the illustrated embodiment has first 54 andsecond 56 support arms that are connected together through an actuationguide member 58 such that support structure 48 is shaped in the form ofa “C”. Opposite guide member 58, the first 54 and second 56 support armsrespectively have first 60 and second 62 motor mounts in which the motor50 is mounted. The illustrated motor 50 has a generally cylindricalshape, but it is contemplated that motor 50 can have other shapes. Asillustrated, motor mounts 60 and 62 each have a hollow cylindrical shapeso as to coincide with the cylindrical shape of the motor 50 such thatmotor 50 is able to fit inside mounts 60 and 62. However, it should beappreciated that motor mounts 60 and 62 can be shaped differently so asto coincide with the shape of differently shaped motors.

[0038] In the illustrated embodiment, the motor 50 includes a reversibleelectric motor, but it should be appreciated that motor 50 can includeother types of motors, such as a pneumatic motor. Moreover, in anotherembodiment in which the motor 50 is non-reversible, the device 30 caninclude as transmission configured to reverse the outputted force fromthe motor 50. In one embodiment, the motor 50 is powered by an internalpower source, such as a battery or a fuel cell, but it is contemplatedthat the motor 50 can be powered in other manners, such as externallythrough an electrical outlet. As depicted in FIGS. 1 and 2, the motor 50has a drive shaft with a drive gear 64 that extends through the firstsupport arm 54. A reduction gear 66, which is rotatably mounted to thefirst support arm 54, operatively engages the drive gear 64 of the motor50. The firing mechanism 52 includes a guide rod 68 that extends betweenthe first 54 and second 56 support arms along longitudinal axis L of thedevice 30. As illustrated, the guide rod 68 is rotatably mounted to thefirst 54 and second 56 support arms via first 70 and second 72 bushings,respectively. At the first support arm 54, the guide rod 68 operativelyengages the reduction gear 66 such that the motor 50 is able to rotatethe guide rod 68. A drive thread or coil 74, which winds in a helicalpattern around the guide rod 68, is attached to the guide rod 68 at bothends through bushings 70 and 72 in one embodiment. In anotherembodiment, the ends of the drive thread 74 are directly attached to theguide rod 68. As noted above, the guide rod 68 is operatively engaged tothe motor 50 via the reduction gear 66. Both the guide rod 68 and thedrive thread 74, in the illustrated embodiment, rotate in unison as themotor 50 rotates the reduction gear 66. It is contemplated that inanother embodiment only the drive thread 74 operatively engages thereduction gear 66 such that the guide rod 68 remains stationary as thedrive thread 74 rotates.

[0039] Referring to FIG. 2, the firing mechanism 52 further includes adrive member 76 that engages the drive thread 74 and an actuation member78 that is coupled to holder 38. A spring (or elastic means) 80 iscoupled between the drive member 76 and the actuation member 78. Amongits many functions, the spring 80 is used to fire the lancet 42 fromdevice 36. During cocking, the motor 50 via drive thread 74 drives thedrive member 76 towards the actuation member 78 such that the spring 80is compressed therebetween. As will be described in greater detailbelow, the potential energy stored by the compressed spring 80 is thenused to fire the actuation member 78, which in turn extends the lancet42 from the integrated lancet/sampling device 36.

[0040] As depicted, the drive member 76 has a rod engagement portion 82that is slidably received along the guide rod 68. In FIG. 2, the rodengagement portion 82 is positioned inside the drive thread 74 and hasone or more thread engaging arms 84 extending therefrom that engage thedrive thread 74. In the illustrated embodiment, the rod engagementportion 82 has a pair of L-shaped thread engaging arms 84 positioned onopposite sides of the rod engagement portion 82, and the thread engagingarms 84 extend through the drive thread 74. It should be appreciatedthat the rod engagement portion can include more or less thread engagingarms 82 than is shown. Through the engagement between the drive thread74 and the thread engaging arms 84, the motor 50 is able to move thedrive member 76 along longitudinal axis L in either a driving directionD or a retraction direction R. For example, rotating the drive thread 74in a clockwise fashion moves the drive member 76 in direction D, androtating the drive thread 74 in a counterclockwise fashion moves thedrive member 76 in direction R. It should be appreciated, however, thatthe drive thread 74 in other embodiments can be coiled in an oppositefashion such that the drive thread 74 can be rotated in clockwisedirection to move the drive member 76 in direction R andcounterclockwise to move the drive member 76 in direction D.

[0041] The drive member 76 further includes a spring engagement portion86 and an actuation member engagement portion 88. As shown, the spring80 is attached to the spring engagement portion 86, and the threadengaging arms 84 attach the rod engagement portion 82 to the springengagement portion 86. In the illustrated embodiment, the springengagement portion 86 is ring shaped so as to fit around the drivethread 74. One or more guide arms 90 connect the spring engagementportion 86 to the actuation member engagement portion 88. As shown, thedrive member 76 in the illustrated embodiment has a pair of guide arms90 that are disposed on opposite sides of the drive member 76. At leastone of the guide arms 90 is constructed to include a guide tab 92 thatis slidably received between a pair of guide rails 94 that extend fromthe guide member 58 of the support structure 48. It, however, should beunderstood that device 30 can include more or less guide arms 90 andguide rails 94 than is shown. The guide rails 94 in conjunction with theguide tab 92 direct the drive member 76 to move along the longitudinalaxis L and prevent the drive member 76 from rotating in response to therotation of the drive thread 74. Referring to FIG. 2, portion 88 of thedrive member 74 defines a spring opening 96 through which the spring 80,the drive thread 74 and the guide rod 68 extend. Around opening 96 thedrive member 76 defines one or more engagement notches 98 in which theactuation member 78 is slidably received.

[0042] With reference to FIG. 1, the actuation member 78 includes one ormore (and in the illustrated embodiment a pair of) slide arms 100 thatare slidably received in the engagement notches 98 defined in the drivemember 78. Each of the slide arms 100 has a stop tab 102 located at theend proximal the drive member 76. As shown, the stop tab 102 has abeveled insertion surface 104 that aids in slidably attaching theactuation member 78 to portion 88 of the drive member 76. At the secondsupport arm 56, the slide arms 100 extend through slide arm openings 106that are defined in the second support arm 56 such that the slide arms100 are able to move in a sliding fashion through openings 106. The endsof the slide arms 100 that are connected to the holder 38 are connectedtogether via a connection member 108. In the support structure 48, theslide arms 100 are connected to together through a cocking flange 110.In the illustrated embodiment, the cocking flange 110 is ring shaped anddefines a thread opening 112 through which the drive thread 74 extends.

[0043] As shown in FIG. 2, the spring 80 is attached to the cockingflange 110 such that the spring 80 is coupled between the springengagement portion 86 of the drive member 76 and the cocking flange 110of the actuation member 78. During cocking of the device 30, the motor50 rotates the drive thread 74 so that the drive member 76 is driventoward the cocking flange 110 of the actuation member 78. As the drivemember 76 is driven towards flange 110, a pair of cocking arms 114,which extend from the second support arm 56 in a parallel arrangementwith respect to the longitudinal axis L, support the cocking flange 110against the force applied by the spring 80. It should be appreciatedthat device 30 in other embodiments can include one or more cocking arms114. The cocking arms 114 have support tabs 116 that face one another inorder to support the cocking flange 110 during cocking. Proximal thedrive member 76, the cocking arms 114 have drive member engagementsurfaces 118 with an angled or beveled shape. Similarly, the drivemember 76 has cocking arm engagement surfaces 120 that are likewisebeveled or angled to coincide with the shape of the drive memberengagement surfaces 118. As the drive member 76 is driven towards thecocking arms 114 during cocking, the cocking arm engagement surfaces 120spread the cocking arms 114 apart such that the cocking flange 110 isreleased. Upon flange 110 being released, the compressed spring 80drives the cocking flange 110 away from the drive member 76, therebydriving the integrated lancet/sampling device 36 to lance the skin. Asdepicted in FIG. 2, the cocking arms 114 further have reengagementsurfaces 122 that are angled in order to allow the cocking flange 110 toreengage the support tabs 116.

[0044] The operation of the integrated bodily fluid sampling device 30according to one embodiment will now be described with reference toFIGS. 1, 2, 3, 4 and 5. FIGS. 3, 4 and 5 illustrate the relativeposition of the sampling device 36 in relation to skin S during thesampling technique according to one embodiment of the present invention.In the illustrated embodiment, device 30 has a housing 124 that iscoupled to the support structure 48, and as shown, the housing 124includes a skin contact portion 126, which surrounds the sampling device36, so as to position device 30 with the skin S. In one form, the skincontact portion 126 is cylindrical in shape, but it is should beappreciated that the skin contact portion 126 can be shaped differently.Moreover, it is contemplated that in other embodiments the skin contactportion 126 can be entirely or partially omitted such that the personusing the fluid sampling device 30 manually holds device 30 in positionover the skin S. The skin contact portion 126 in the illustratedembodiment is sized so as to not to apply force to the skin that canclose incision I once formed.

[0045] Initially, the cocking flange 110 of the firing mechanism 52engages the support tabs 116 of the cocking arms 114, as is shown inFIG. 1. In on order to initiate lancing, the user positions device 36either in contact with or proximal to the skin S. In the embodimentillustrated in FIG. 3, the user presses the skin contact portion 126against the skin S so as to position device 36. To cock the firingmechanism 52, as depicted in FIG. 2, the motor 50 via reduction gear 66rotates the drive thread 74 so that the drive member 76 is driven indriving direction D along longitudinal axis L towards the cocking flange110 of the actuation member 78. Cocking can be initiated by the userthrough a switch on device 30 that activates the motor 50 and/orautomatically through a controller in the device 30. It should beappreciated that the motor 50 can be activated in other manners. Sincethe cocking flange 110 is engaged with the cocking arms 114, the spring80 in the firing mechanism 52 becomes compressed as the drive member 76is driven in direction D. When the drive member 76 is further driven indirection D, the stop tabs 102 of the actuation member 78 disengage fromthe actuation member engagement portion 88 of the drive member 76 suchthat the slide arms 100 slide within the engagement openings 98 of thedrive member 76. Eventually, as the spring 80 becomes further compressedby the drive member 76, the arm engagement surfaces 120 on the drivemember 76 engage the drive member engagement surfaces 118 on the cockingarms 114 such that the cocking arms 114 are pried apart from oneanother. Once arms 114 are sufficiently bent away from one another, thesupport tabs 116 on the cocking arms 114 disengage from the cockingflange 110.

[0046] As soon as the cocking flange 110 is disengaged, the compressedspring 80 expands so as to drive the actuation member 78 in direction Dtowards the skin. After the firing mechanism 52 is fired, the motor 50in one embodiment stops driving the drive member 76. In one form, atimer is used to control the operation of the motor 50. Nevertheless, itis contemplated that the motor 50 can be controlled in other manners,such as through a controller and sensors. When the actuation member 78is fired, the actuation member 78 presses the casing 44 of theintegrated lancet/sampling device 36 against the skin, and the lancet 42inside the casing 44 slides relative to the casing 44 so as to extendfrom the casing 44, thereby lancing the incision I in the skin S (FIG.3). The depth control mechanism 40 controls the penetration depth of thelancet 42. Once the incision of the proper depth is formed, a retractionmechanism, such as a leaf spring in device 36, retracts the lancet 42back inside the casing 44. In addition, the forward progression of theactuation member 78 in direction D is stopped in one embodiment by thestop tabs 102 contacting the actuation member engagement portion 88 onthe drive member 76. In another embodiment, the movement of theactuation member 78 is stopped by the cocking flange 110 hitting thesecond support arm 56.

[0047] To prevent the pressure applied by the casing 44 from prematurelyclosing the incision, thereby limiting the fluid supplied from theincision, the bodily fluid sampling device 30 according to oneembodiment of the present invention temporarily lifts the integratedlancet/sampling device 36 in direction R from the skin, as is shown inFIG. 4. Afterwards, the bodily fluid sampling device 30 reapplies thecasing 44 of device 36 against the skin or positions device 36 proximalthe skin such that the integrated lancet/sampling device 36 is able tocollect a fluid sample from the incision, as is illustrated in FIG. 5.As should be appreciated, this sampling technique according to thepresent invention increases the size of the fluid sample by notrestricting the fluid flow from the incision I. In one embodiment, thebodily fluid sampling device 30 lifts the integrated lancet/samplingdevice 36 for two (2) seconds before reapplying device 36 against theskin. However, it should be appreciated that device 36 can betemporarily lifted from the skin for different time intervals. Totemporarily remove device 36 from the skin S, the motor 50 in FIG. 2 isreversed such that the drive thread 74 is rotated in an oppositedirection (as compared to when cocking the firing mechanism), therebymoving the drive member 76 in retraction direction R. For example, thedrive thread 74 can be rotated in a clockwise direction to move drivemember 76 in direction D and can be rotated in a counterclockwisedirection so as to move the drive member 76 in direction R. As should beappreciated, the drive member 76 in other embodiments can be advanced indirection D and retracted in direction R by rotating the drive thread 74in an opposite fashion. While the drive member 76 is driven in directionR, the stop tabs 102, which engage the drive member 76, also pull theactuation member 78 in direction R. When the actuation member 78 ismoved in direction R, device 36 is likewise moved in direction R,thereby lifting the casing 44 of device 36 from the skin S (FIG. 4). Inone embodiment, the integrated lancet/sampling device 36 is lifted asmall distance from the skin, and in particular, device 36 is lifted 1mm from the skin. It should be appreciated, however, that device 36 canbe retracted at different distances from the skin.

[0048] Once device 36 has been lifted from the skin for a short periodof time, the motor 50 is then again reversed so as to drive the drivemember 76 in direction D. The force applied by the drive member 76against the spring 80 is transferred to the actuation member 78 so thatdevice 36 is moved in direction D towards the skin (FIG. 5). When theintegrated lancet/sampling device 36 contacts the skin S or ispositioned at the desired distance from the skin S, the motor 50 can bedeenergized. The bodily fluid F that has formed as a droplet from theincision I in the skin S is drawn via capillary action into thecapillary cavity formed in the casing 44 and deposited onto the teststrip 46 in device 36 so that the fluid sample can be analyzed.

[0049] To reset the bodily fluid sampling device 30 for future samplecollection, the motor 50 drives the drive member 76 in the retractiondirection R such that the actuation mechanism 78 is likewise pulled inthe retraction direction R. As the actuation mechanism 78 is pulled indirection R, the cocking flange 110 engages the reengagement surfaces122 on the cocking arms 114, and the arms 114 are pried apart so thatthe cocking flange 110 reengages the support tabs 116 on the cockingarms 114. Once the bodily fluid sampling device 30 is reset, the firingmechanism 52 can be again cocked and fired in the manner as describedabove.

[0050] It is contemplated that, in another embodiment, a purelymechanical device can be used to accomplish the sampling technique asdescribed above in which the integrated lancet/sampling device istemporarily removed and reapplied to the skin. In one form, a hydraulicand/or pneumatic cylinder is used to dampen or slow the mechanicalmovement in which the integrated lancet/sampling device is temporarilyremoved and reapplied.

[0051] While the invention has been illustrated and described in detailin the drawings and foregoing description, the same is to be consideredas illustrative and not restrictive in character, it being understoodthat only the preferred embodiment has been shown and described and thatall changes and modifications that come within the spirit of theinvention are desired to be protected.

What is claimed is:
 1. A method, comprising: forming an incision in skinwith a sampling end portion of a body fluid sampling device; retractingthe sampling end portion from the skin to promote flow of body fluidfrom the incision; and collecting the body fluid from the incision withthe sampling end portion of the body fluid sampling device by extendingthe sampling end portion toward the skin after said retracting.
 2. Themethod of claim 1, wherein: the sampling end portion includes anintegrated lancing-sampling device that includes a casing that defines acavity and a lancet slidably received in the cavity; said forming theincision includes lancing the skin with the lancet by pressing thecasing against the skin to expose the lancet; and said collecting thebody fluid includes drawing the body fluid into the cavity via capillaryaction.
 3. The method of claim 2, further comprising: wherein theintegrated lancing-sampling device includes a test strip positionedalong the cavity; and analyzing the body fluid with the test strip. 4.The method of claim 1, further comprising analyzing the body fluid at atest area in the body fluid sampling device.
 5. The method of claim 1,wherein: the sampling device includes a retraction mechanism, theretraction member includes a motor, a drive thread coupled to the motor,a drive member coupled to the drive thread, an actuation member coupledto the drive member, and a spring coupled between the drive member andthe actuation member; and said retracting includes actuating the motorto retract the sampling end portion.
 6. The method of claim 1, whereinsaid retracting includes retracting the sampling end portion for atleast two seconds before said collecting.
 7. The method of claim 1,further comprising: wherein the body fluid sampling device includes alancing mechanism with a motor; and cocking the lancing mechanism withthe motor before said forming the incision.
 8. The method of claim 1,wherein said collecting includes pressing the sampling end portionagainst the skin.
 9. The method of claim 1, wherein said collectingincludes positioning the sampling end portion above the skin in anon-contacting manner.
 10. A body fluid sampling device, comprising: alancing device adapted to lance an incision in skin; a firing mechanismcoupled to the lancing device, the firing mechanism having a cockedconfiguration in which the firing mechanism is cocked for firing thelancing device; and a motor coupled to the firing mechanism adapted toplace the firing mechanism in the cocked configuration.
 11. The deviceof claim 10, wherein: the firing mechanism includes a spring that iscoupled between the motor and the lancing device for firing the lancingdevice; and the motor is operable to compress the spring to place thefiring mechanism in the cocked configuration.
 12. The device of claim11, further comprising: wherein the firing mechanism includes anactuation member coupled to the lancing device and the spring; a drivemember coupled to the spring and motor; wherein the motor is adapted tomove the drive member to compress the spring between the actuationmember and the drive member.
 13. The device of claim 12, furthercomprising: one or more cocking arms that engage the actuation memberduring cocking; and wherein the drive member has one or more engagementsurfaces that are adapted to engage the cocking arms to release theactuation member from the cocking arms for firing the lancing device.14. The device of claim 13, wherein the engagement surfaces areconfigured to spread the cocking arms apart to release the actuationmember.
 15. The device of claim 13, wherein: the actuation member isslidably coupled to the drive member; and the actuation member includesa stop tab engageable with the drive member to retract the lancingdevice from the skin.
 16. The device of claim 13, further comprising: asupport structure coupled to the motor; a guide rod having a drivethread rotatably mounted to the support structure, the drive threadengages the drive member to move the drive member; and a gear coupledbetween the motor and the guide rod for transmitting rotational forcefrom the motor to the guide rod.
 17. The device of claim 10, wherein thelancing device include an integrated lancing-sampling device thatincludes a casing defining a lancet cavity, a lancet for lancing theskin slidably received in the lancet cavity and a test means positionedalong the lancet cavity to test body fluid drawn into the lancet cavityfrom the incision.
 18. The device of claim 17, further comprising meansfor temporarily retracting the integrated lancing-sampling device fromthe skin to promote flow of the body fluid from the incision.
 19. Thedevice of claim 10, wherein the motor includes a reversible motor toretract the lancing device from the skin.
 20. The device of claim 10,wherein the motor includes an electric motor.
 21. A body fluid samplingdevice, comprising: an integrated lancing-sampling device including acasing and a lancet for lancing an incision in skin slidably received inthe casing, wherein the casing defines a sampling cavity for drawingbody fluid from the incision; and means for retracting and reapplyingthe integrated lancing-sampling device against the skin to promote flowof body fluid from the incision.
 22. The device of claim 21, wherein themeans for retracting and reapplying the integrated lancing-samplingdevice includes a motor operable to retract and reapply the integratedlancing-sampling device against the skin.
 23. The device of claim 21,further comprising: a firing mechanism coupled to theintegrated-sampling device for firing the integrated lancing-samplingdevice; and means for automatically cocking the firing mechanism. 24.The device of claim 21, further comprising a depth control mechanismcoupled to the integrated lancing-sampling device to adjust thepenetration depth of the lancet.